Acne VulgarisPhase 4NCT00469755
Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne
A Phase 4 study testing Adapalene Gel, 0.1%, Tazarotene Cream, 0.1% and Adapalene Gel, 0.1% + Tazarotene Cream, 0.1% in people with Acne Vulgaris, run by Galderma R&D at 12 sites in United States.
Trial summary
To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Adapalene Gel, 0.1%, Tazarotene Cream, 0.1% and Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 12 sitesUnited States
- Study dates
- Feb 2006to Sep 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face
- Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose
Who cannot join
- Subjects with more than 3 nodulo-cystic lesions
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
DermResearch, Inc.
Austin, Texas, 78759
State University of New York Downstate Medical Center-Dept. of Dermatology
Brooklyn, New York, 11203
J & S Studies, Inc.
Bryan, Texas, 77802
Stephens & Associates
Carrollton, Texas, 75006
Dermatology Research Associates
Cincinnati, Ohio, 45230
Henry Ford Medical Center-Dept. of Dermatology
Detroit, Michigan, 48202
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Milton S. Hershey Medical Center Center-Div. of Dermatology
Hershey, Pennsylvania, 17033-0850
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Phoebe Rich, MD & Associates
Portland, Oregon, 97210
Dermatology Research Center
Salt Lake City, Utah, 84124
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A Comparison of Differin® Gel, 0.1% vs. Tazorac® Cream, 0.1% vs. Differin® Gel, 0.1% 6-week Treatment Switched to Tazorac® Cream, 0.1% 6-week Treatment in Patients With Acne Vulgaris
To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream
Read the detailed description
Same as above.
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene Gel, 0.1%, Tazarotene Cream, 0.1%, Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapalene Gel, 0.1%Drug
Also called Differin® Gel, 0.1%
Apply once daily in the evening for 12 weeks
Tazarotene Cream, 0.1%Drug
Also called Tazorac® Cream, 0.1%
Apply once daily in the evening for 12 weeks
Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%Drug
Also called Differin® Gel, 0.1% and Tazorac® Cream, 0.1%
Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Differin® Gel, 0.1% for 12 weeks Receives: Drug: Adapalene Gel, 0.1% |
| 2 | Active comparator | Tazorac® Cream, 0.1% for 12 weeks Receives: Drug: Tazarotene Cream, 0.1% |
| 3 | Active comparator | Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks Receives: Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - total lesion counts
Measured: 12 weeks
Secondary outcomes (1)
Safety - tolerability assessments and adverse event reporting
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startFeb 2006
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ronald W Gottschalk, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469755
- Sponsor's protocol ID
- US10026
- Status last verified
- Mar 2008
- First submitted
- 2 May 2007
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Differin® Gel, 0.1% vs. Tazorac® Cream, 0.1% vs. Differin® Gel, 0.1% 6-week Treatment Switched to Tazorac® Cream, 0.1% 6-week Treatment in Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00469755
- Acronym / sponsor ID
- US10026
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 4 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream
Detailed description
Same as above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Adapalene Gel, 0.1%Differin® Gel, 0.1% for 12 weeks |
| 2 | Active comparator | Drug: Tazarotene Cream, 0.1%Tazorac® Cream, 0.1% for 12 weeks |
| 3 | Active comparator | Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face
- Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose
Key exclusion criteria (1 listed)
- Subjects with more than 3 nodulo-cystic lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapalene Gel, 0.1%Also: Differin® Gel, 0.1%Apply once daily in the evening for 12 weeks | Drug | 1 |
| Tazarotene Cream, 0.1%Also: Tazorac® Cream, 0.1%Apply once daily in the evening for 12 weeks | Drug | 2 |
| Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%Also: Differin® Gel, 0.1% and Tazorac® Cream, 0.1%Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks | Drug | 3 |
Primary outcome
Efficacy - total lesion counts
Time frame: 12 weeks
1 secondary outcome
Safety - tolerability assessments and adverse event reporting
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald W Gottschalk, MD study director
Galderma R&D
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adapalene Gel, 0.1%, Tazarotene Cream, 0.1% and Adapalene Gel, 0.1% + Tazarotene Cream, 0.1% in people with Acne Vulgaris, run by Galderma R&D at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - total lesion counts (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.